1. Field of the Invention
The present invention concerns the application of a probe operative in the mid- or near-infrared (“IR”) region of the electromagnetic spectrum (“EM”) for in situ sensing of the absorption of infrared energy or reflected infrared energy of a material that has a distinguishable infrared spectrum and removing such material with a combined ablator, cutter, carver or polisher.
More specifically, the present invention concerns the application of a probe operative in the mid- or near-IR region of the EM for in situ sensing of the absorption of infrared energy or reflected infrared energy for distinguishing between two materials that have different infrared spectra and separating or removing one material from the other with an ablator, cutter, carver or polisher.
In a particular embodiment, the present invention relates to the application of a probe operative in the mid- or near-IR region of the EM for in situ sensing of the absorption of infrared energy or reflected infrared energy for (i) discriminating between a host tissue and a non-host material in situ or in vivo, and (ii) in combination with an ablator, cutter, carver or polisher, separating the non-host material from the host tissue in situ or in vivo.
2. Background Information
There is a need for identifying different materials in contact with each other and simultaneously removing one of such materials by, for example, ablation, for example, separating a non-host material from a host material in situ or in vivo, or carving or polishing a resin in the presence of another material.
Advances in biomaterials and tissue engineering have made a significant impact in health care over the last few decades. A multitude of materials or systems that replace or help to regenerate human tissue to restore function have been developed. Materials such as metals, polymers, ceramics, glass, composites and bone substitutes have been implanted primarily for orthopedic applications (Sedel L., (2000), “Evolution of Alumina-on-Alumina Implants: A Review”, Clin. Orthop., 48–54; Santavirta S., Takagi M., Gomez-Barrena E., Nevalainen J., Lassus J., Salo J., et al., (1999), “Studies of Host Response to Orthopedic Implants and Biomaterials”, J. Long Term Eff. Med. Implants., 9:67–76; Behravesh E., Yasko A. W., Engel P. S., Mikos A. G., (1999), “Synthetic Biodegradable Polymers for Orthopaedic Applications”, Clin. Orthop., S118–S129; Khan S. N., Sandhu H. S., Parvataneni H. K., Girardi F. P., Cammisa F. P., (2000), “Bone Graft Substitutes in Spine Surgery”, Bull. Hosp. Jt. Dis., 59:5–10; Willmann G., (2000), “Ceramic Femoral Head Retrieval Data”, Clin. Orthop., 22–28; Bostman O., Pihlajamaki H., (2000), “Clinical Biocompatibility of Biodegradable Orthopaedic Implants for Internal Fixation: A Review”, Biomaterials, 21:2615–2621; Fujikawa K., Kobayashi T., Sasazaki Y., Matsumoto H., Seedhom B. B., (2000), “Anterior Cruciate Ligament Reconstruction with the Leeds-Keio Artificial Ligament”, J. Long Term Eff. Med. Implants, 10:225–238; Marti A., (2000), “Cobalt-Base Alloys Used in Bone Surgery”, Injury 31 Suppl., 4:18–21). Other bioactive or biodegradable materials, drugs, scaffolds, cells and various synthetic components have been utilized in vivo for many other tissue engineering applications (Pietrzak W. S., (2000), “Principles of Development and Use of Absorbable Internal Fixation”, Tissue Eng., 6:425–433; Cordewener F. W., Schmitz J. P., (2000), “The Future of Biodegradable Osteosyntheses”, Tissue Eng., 6:413–424; Boden S. D., (2000), “Biology of Lumbar Spine Fusion and Use of Bone Graft Substitutes: Present, Future, and Next Generation”, Tissue Eng., 6:383–399; Reddi A. H., (2000), “Morphogenesis and Tissue Engineering of Bone and Cartilage: Inductive Signals, Stem Cells, and Biomimetic Biomaterials”, Tissue Eng., 6:351–359; Hollinger J. O., Winn S., Bonadio J., (2000), “Options for Tissue Engineering to Address Challenges of the Aging Skeleton”, Tissue Eng., 6:341–350; Caplan A. I., (2000), “Tissue Engineering Designs for the Future: New Logics, Old Molecules”, Tissue Eng., 6:1–8). Commensurate with such developments is the requirement for new methodology to evaluate the integration of “non-host” materials into host tissue, to assess their capability for regeneration and repair of the tissue, and to discern between the non-host material and the host tissue in situ.
Although at times it is possible to distinguish the non-host components from host tissues in situ, there are many situations where this is not possible by visual examination alone. One example is the use of bone cement, polymethyl methacrylate (“PMMA”), in orthopaedic surgery. PMMA is utilized frequently to cement components used in joint arthroplasty, such as hip stems, to the bone. When revision surgery is necessary to replace the old hip stem with a new one, it is extremely difficult for the surgeon to visually discern the PMMA from the bone in the femoral canal, and thus to adequately remove it. Another example is the discrimination and/or removal of PMMA cement or fillings from teeth. Although metal fillings can easily be discerned from teeth, it is sometimes difficult to discern non-amalgam-based fillings made of composite materials (Krejci I., Schupbach P., Balmelli F., Lutz F., (1999), “The Ultrastructure of a Compomer Adhesive Interface in Enamel and Dentin, and its Marginal Adaptation Under Dentinal Fluid as Compared to that of a Composite”, Dent. Mater., 15:349–358; Lutz F., Krejci I., (2000), “Amalgam Substitutes: A Critical Analysis”, J. Esthet. Dent., 12:146–159; Tate W. H., You C., Powers J. M., (2000), “Bond Strength of Compomers to Human Enamel”, Oper. Dent., 25:283–291; Attin T., Opatowski A., Meyer C., Zingg-Meyer B., Monting J. S., (2000), “Class II Restorations With a Polyacid-Modified Composite Resin in Primary Molars Placed in a Dental Practice: Results of a Two-Year Clinical Evaluation”, Oper. Dent., 25:259–264) or PMMA cement, from the tooth itself. The availability of a technique which could be conveniently utilized in situ to discriminate between a host tissue and a non-host material would be very advantageous for the medical and dental fields.
The techniques of mid- and near-infrared spectroscopy have been utilized extensively in the biomedical field. Mid-infrared spectroscopy has been utilized to study biological molecules (reviewed in “Infrared and Raman Spectroscopy of Biological Materials”, New York, Marcel Dekker, 2001), including bone (Boskey A. L., Gadaleta S., Gundberg C., Doty S. B., Ducy P., Karsenty G., (1998), “Fourier Transform Infrared Microspectroscopic Analysis of Bones of Osteocalcin-deficient Mice Provides Insight into the Function of Osteocalcin”, Bone. 23:187–196; Camacho N. P., Rimnac C., Meyer R., Jr., Doty S. Boskey A., (1995), “Effect of Abnormal Mineralization on the Mechanical Behavior of X-Linked Hypophosphatemic Mice Femora”, [published erratum appears in Bone, July 1996, ] 19(1):77, Bone, 17:271–278; Camacho N. P., Landis W. J., Boskey A. L., (1996), “Mineral Changes in a Mouse Model of Osteogenesis Imperfecta Detected by Fourier Transform Infrared Microscopy”, Connect. Tissue Res., 35:25–265; Camacho N. P., Hou L., Toledano T. R., Ilg W. A., Brayton C. F., Raggio C. L., et al., (1999), “The Material Basis for Reduced Mechanical Properties in Oim Mice Bones”, J. Bone Miner. Res., 14:264–272; Paschalis E. P., DiCarlo E., Betts F., Sherman P., Mendelsohn R., Boskey A. L., (1996), “FTIR Microspectroscopic Analysis of Human Osteonal Bone”, Calcif. Tissue Int., 59:480–487; Paschalis E. P., Jacenko O., Olsen B., deCrombrugghe B., Boskey A. L., (1996), “The Role of Type X Collagen in Endochondral Ossification as Deduced by Fourier Transform Infrared Microscopy Analysis”, Connect. Tissue Res., 35:371–377; Paschalis E. P., Betts F., DiCarlo E., Mendelsohn R., Boskey A. L., (1997), “FTIR Microspectroscopic Analysis of Normal Human Cortical and Trabecular Bone”, Calcif. Tissue Int., 61:480–486) and cartilage (Potter-K., Kidder L. H., Levin I. W., Lewis E. N., Spencer R. G., (2001), “Imaging of Collagen and Proteoglycan in Cartilage Sections Using Fourier Transform Infrared Spectral Imaging”, Arthritis Rheum., 44:846–855; Camacho N. P., West P., Torzilli P. A., Mendelsohn R., (2001), “FTIR Microscopic Imaging of Collagen and Proteoglycan in Bovine Cartilage”, Biopolymers, 62:1–8), for the analysis of the structure and components of biomaterials (Weng J., Liu Q., Wolke J. G., Zhang X., de Groot K., (1997), “Formation and Characteristics of the Apatite Layer on Plasma-Sprayed Hydroxyapatite Coatings in Simulated Body Fluid”, Biomaterials, 18:1027–1035; Shaw R. A., Eysel H. H., Liu K. Z., Mantsch H. H., (1998), “Infrared Spectroscopic Analysis of Biomedical Specimens Using Glass Substrates”, Anal. Biochem., 259:181–186; Rehman I., Knowles J. C., Bonfield W., (1998), “Analysis of In Vitro Reaction Layers Formed on Bioglass Using Thin-Film X-Ray Diffraction and ATR-FTIR Microspectroscopy”, J. Biomed. Mater. Res., 41:162–166; Zhang, S. F., Rolfe P., Wright G., Lian W., Milling A. J., Tanaka S., et al., (1998), “Physical and Biological Properties of Compound Membranes Incorporating a Copolymer with a Phosphorylcholine Head Group”, Biomaterials, 19:691–700; Rehman I., Karsh M., Hench L. L., Bonfield W., (2000), “Analysis of Apatite Layers on Glass-Ceramic Particulate Using FTIR and FT-Raman Spectroscopy”, J. Biomed. Mater. Res., 50:97–100; Collier J. H., Camp J. P., Hudson T. W., Schmidt C. E., (2000), “Synthesis and Characterization of PolypyrroleHyaluronic Acid Composite Biomaterials for Tissue Engineering Applications”, J. Biomed. Mater. Res., 50:574–584) and recently, has been proposed as a technique to evaluate malignancy in tissue (Schultz C. P., Liu K. Z., Kerr P. D., Mantsch H. H., (1998), “In Situ Infrared Histopathology of Keratinization in Human Oral/Oropharyngeal Squamous Cell Carcinoma”, Oncol. Res., 10:277–286; Fukuyama Y., Yoshida S., Yanagisawa S., Shimizu M., (1999), “A Study on the Differences Between Oral Squamous Cell Carcinomas and Normal Oral Mucosas Measured by Fourier Transform Infrared Spectroscopy”, Biospectroscopy, 5:117–126; McIntosh L. M., Jackson M., Mantsch H. H., Stranc M. F., Pilavdzic D., Crowson A. N., (1999), “Infrared Spectra of Basal Cell Carcinomas are Distinct from Non-Tumor-Baring Skin Components”, J. Invest. Dermatol., 112:951–956; Boydston-White S., Gopen T., Houser S., Bargonetti J., Diem M., (1999), “Infrared Spectroscopy of Human Tissue. V. Infrared Spectroscopic Studies of Myeloid Leukemia (ML-1) Cells at Different Phases of the Cell Cycle”, Biospectroscopy, 5:219–227; Shaw R. A., Guijon F. B., Paraskevas M., Ying S. L., Mantsch H. H., (1999), “Infrared Spectroscopy of Exfoliated Cervical Cell Specimens, Proceed with Caution”, Anal. Quant. Cytol. Histol., 21:292–302).
Near-infrared spectroscopy has been used to study hemoglobin oxygen saturation (Hull E. L., Conover D. L., Foster T. H., (1999), “Carbogen-Induced Changes in Rat Mammary Tumour Oxygenation Reported by Near Infrared Spectroscopy”, Br. J. Cancer, 79:1709–1716; Quaresima V., Sacco S., Totaro R., Ferrari M., (2000), “Non-invasive Measurement of Cerebral Hemoglobin Oxygen Saturation Using Two Near Infrared Spectroscopy Approaches”, J. Biomed. Opt., 5:201–205; Feng W., Haishu D., Fenghua T., Jun Z., Qing X., Xianwu T., (2001), “Influence of Overlying Tissue and Probe Geometry on the Sensitivity of a Near-Infrared Tissue Oximeter”, Physiol. Meas., 22:201–208), and in conjunction with a fiber optic probe, to study water content and product quality in the pharmaceutical industry (White J. G., (1994), “On-line Moisture Detection for a Microwave Vacuum Dryer”, Pharm. Res., 11:728–732; Blanco M., Coello J., Iturriaga H., Maspoch S., Rovira E., (1997), “Determination of Water in Ferrous Lactate by Near Infrared Reflectance Spectroscopy with a Fibre-Optic Probe”, J. Pharm. Biomed. Anal., 16:255–262; Bouveresse E., Casolino C., de la P. C., (1998), “Application of Standardisation Methods to Correct the Spectral Differences Induced by a Fibre Optic Probe Used For the Near-Infrared Analysis of Pharmaceutical Tablets”, J. Pharm. Biomed. Anal., 18:35–42; Andersson M., Folestad S., Gottfries J., Johansson M. O., Josefson M., Wahlund K. G., (2000), “Quantitative Analysis of Film Coating in a Fluidized Bed Process by In-Line NIR Spectrometry and Multivariate Batch Calibration”, Anal. Chem., 72:2099–2108; Harris S. C., Walker D. S., (2000), “Quantitative Real-Time Monitoring of Dryer Effluent Using Fiber Optic Near-Infrared Spectroscopy”, J. Pharm. Sci., 89:1180–1186).
To date, mid-infrared fiber optic spectroscopic applications in the biomedical field have been limited, but include non-invasive blood glucose measurement (Uemura T., Nishida K., Sakakida M., Ichinose K., Shimoda S., Shichiri M., (1999), “Non-Invasive Blood Glucose Measurement by Fourier Transform Infrared Spectroscopic Analysis Through the Mucous Membrane of the Lip: Application of a Chalcogenide Optical Fiber System”, Front. Med. Biol. Eng., 9:137–153), the study of bio-reactions (Dadd M. R., Sharp D. C., Pettman A. J., Knowles C. J., (2000), “Real-Time Monitoring of Nitrile Biotransformations by Mid-Infrared Spectroscopy”, J. Microbiol. Methods, 41:69–75; Doak D. L., Phillips J. A., (1999), “In Situ Monitoring of an Escherichia Coli Fermentation Using a Diamond Composition ATR Probe and Mid-Infrared Spectroscopy”, Biotechnol. Prog., 15:529–539), and most recently, the evaluation of cartilage degradation (Bostrom M. P. G., West P., Yang X., Camacho N. P., “Evaluation of Cartilage Degradation by an Infrared Fiber Optic Probe”, presented at the 4th Combined Meeting of the Orthopaedic Research Society, 2001; Camacho N. P., Lin J., Yang X., West P. and Bostrom M. P. G., “An Infrared Fiber Optic Probe for Detection of Degenerative Cartilage”, Trans 48th ORS Meeting, 2002 (Abstract)).
The following U.S. patents relate to the selective removal of materials such as paint using laser or other optical energy: U.S. Pat. Nos. 4,588,885; 5,204,517; 5,286,947 and 5,281,798.
The following U.S. patents concern the use of electromagnetic energy to distinguish tissue and involve an ablation, cutting or removal of material: U.S. Pat. Nos. 3,769,963; 4,737,628; 5,197,470; 5,346,488 and 6,200,307.
Lovoi et al. U.S. Pat. No. 4,737,628 concern a method and system for controlled selective removal of material such as a tumor or a substance causing a blood vessel blockage using a “high intensity beam of radiant energy” impinging from a distance to the material to be removed.
Helfer et al. U.S. Pat. No. 5,197,470 concern an instrument and a method for using near IR to discriminate between healthy and diseased tissue using a laser to ablate unwanted tissue, also impinging from a distance to the tissue.
Goldman et al. U.S. Pat. No. 3,769,963 disclose an instrument for performing laser micro-surgery and diagnostic transillumination of tissue such that different wavelengths are used to illuminate different objects or tissue that can then be selectively removed by a surgical laser.
None of the above U.S. patents disclose the use of an infrared fiber optic probe (“IFOP”) in contact with a sample or material for detecting its infrared spectrum. Moreover, none of the above U.S. patents disclose an ultrasonic ablator to remove undesired material.